A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma

Completed

• Conditions: Intrahepatic Cholangiocarcinoma; Machine Learning
• Interventions: Procedure: lymph nodes dissection

• Registration Number: NCT06290739
• Lead Sponsor: West China Hospital

Brief Summary

The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

• 1.Patients who were confirmed with intrahepatic cholangiocarcinoma 2. curative-intent hepatectomy 3. Without concurrent extrahepatic disease

Exclusion Criteria

• 1.Patients lacking complete pathology information, 2. Patients who didn't get curative resection 3.Patients with concurrent extrahepatic disease or had missing follow-up data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intrahepatic cholangiocarcinoma patients who underwent lymph nodes dissection	lymph nodes dissection	-

Primary Outcome Measures

Name	Time	Method
Overall survival	2010.01-2019.01	Overall survival (OS) refers to the duration between the commencement of surgery and the patient's demise due to any reason.

Secondary Outcome Measures

Name	Time	Method
Disease free survival	2010.01-2019.01	Disease-free survival (DFS) refers to the period of time from the date of surgery until the occurrence of a relapse either within or outside the liver.

Trial Locations

Locations (1)

Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China